BMS Urges FDA to Clarify Guidance on Risk-Based Trial Monitoring

The agency released the draft in March urging drug sponsors to conduct a series of risk analyses and to develop a risk-monitoring plan as part of their trials. But BMS says the recommendations aren’t clear on the processes by which sponsors ensure that they’re randomizing patients.

It would be better, the pharma giant suggested, to ask drug sponsors to submit “an assessment of potential risks of investigation design and/or blinding and randomization procedures.”

BMS urges the agency to introduce “process-driven categories” of risk-management, noting the  draft guidance seems to suggest that “issue management categories” are essential, when, in fact, a good risk management plan focuses on the end-to-end process and teamwork.